FAMILY STUDY OF CHRONIC POSTTRAUMATIC STRESS DISORDER

慢性创伤后应激障碍的家庭研究

• 批准号: 2675710
• 负责人: JONATHAN R DAVIDSON
• 金额: $ 26.42万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-08-01 至 2001-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2675710
• 关键词: clinical research; drug administration rate /duration; family; fluoxetine; human subject; human therapy evaluation; mental disorder chemotherapy; posttraumatic stress disorder; relapse /recurrence

DESCRIPTION (Adapted from applicant's abstract): PTSD is a chronic and distressing disorder, affecting up to 8 percent of the U.S. population. It is associated with significant morbidity, possible increased mortality and may persist for many years. Controlled studies have shown efficacy for antidepressant drugs in PTSD. Specifically, fluoxetine has been the most studied. No trials have evaluated the effects of long-term pharmacotherapy in PTSD, nor have they looked at the issues of relapse upon discontinuation. Little is known as to the optimum length of pharmacotherapy, or even whether long-term therapy is necessary. In this proposal the investigator aim to assess relapse and recurrence rates of PTSD in 74 patients with PTSD who have responded successfully to 6 months of open-label treatment with fluoxetine (FLU). One-hundred-and-twenty-six subjects will enter open-label treatment with FLU for 6 months. At 6 months, 82 subjects will be randomized to either continue on FLU or placebo (PBO) double-blind for a period of up to 6 months, at which time FLU responders will again be randomized to continue on FLU or receive PBO for a further 3 months, thus providing a total term of 15 months treatment in up to a maximum of 74 patients. The goals of the study are to compare rates of relapse/recurrence in the FLU and PBO groups after each of the discontinuation points. Subjects will initially be diagnosed by the SCID, with symptom severity measures including the CGI, structured interview (SI), Hamilton Scales and self-rating measures for PTSD, to include the Davidson Trauma Scale, Impact of Events Scale Revised and patient Global Improvement. Adverse effects of the medication will also be monitored and compliance checked with pill counts, daily logs and medication levels. The study will provide information about whether there is extended benefit by continuing pharmacotherapy for more than 6 months, whether long-term pharmacotherapy reduces the likelihood of symptom return during 12 months of pharmacotherapy. Health service and cost implications of such findings remain considerable, given the morbidity associated with PTSD.

描述（根据申请人的摘要改编）：PTSD是慢性， 令人困扰的疾病，影响多达8％的美国人口。 它 与明显的发病率相关，可能增加的死亡率和 可能会持续多年。 对照研究表明 PTSD中的抗抑郁药。 具体而言，氟西汀是最多的 研究。 没有试验评估长期药物治疗的影响 在PTSD中，他们也没有研究中断时复发的问题。 鲜为人知的最佳药物治疗长度，甚至是 长期治疗是必要的。 在此提案中，研究者的目的是评估复发和复发率 已成功反应6个月的74例PTSD患者的PTSD 氟西汀开放标签（流感）的处理。 一百六十六 受试者将通过流感进行6个月的开放标签治疗。 在6 月份，将有82名受试者随机分配以继续流感或安慰剂 （PBO）双蓝色长达6个月，此时流感 响应者将再次被随机分配以继续流感或接受PBO 进一步3个月，因此在UP中提供了15个月的治疗 最多有74名患者。 研究的目标是比较 每一个之后，流感和PBO组的复发/复发 中断点。 受试者最初将由SCID诊断，并具有症状严重程度 包括CGI，结构化访谈（SI），汉密尔顿量表和包括的措施 PTSD的自我评价措施，包括戴维森创伤量表，影响 事件规模修订和患者全球改进。 不利影响 该药物也将受到监测，并与药丸检查 计数，每日日志和药物水平。 该研究将提供有关是否有扩展利益的信息 通过继续药物治疗超过6个月，无论长期 药物治疗降低了症状的可能性 药物治疗。 卫生服务和此类发现的成本影响 考虑到与PTSD相关的发病率，保持相当大。